(59 days)
No
The summary mentions "image is digitally processed by control unit with embedded firmware," but there is no mention of AI, ML, or related concepts like training or test sets for algorithms. The performance studies focus on traditional device verification and validation, not algorithmic performance.
No
The device is described as a spinal endoscope for visualization during discectomy procedures and related spinal procedures. It facilitates the use of tools but does not in itself perform a therapeutic function; its purpose is diagnostic (visualization) and to assist with therapeutic procedures performed by other tools.
No
Explanation: The device is an endoscope used for visualization during surgical procedures (discectomy, bone/osteophyte removal, procedures for ruptured/herniated discs). Its purpose is to aid surgeons in navigating and performing these treatments, not to diagnose a condition.
No
The device description clearly states that the system includes physical components such as spinal endoscopes with a light source, camera, HDMI output, irrigation, and a working channel, as well as a control module. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs." This describes a surgical visualization tool used in vivo (within the body) during a medical procedure.
- Device Description: The description confirms it's a "spinal endoscope" providing visualization, irrigation, and a working channel for tools. This aligns with a surgical instrument, not a device used to examine specimens in vitro (outside the body).
- Anatomical Site: The specified anatomical site is within the spine, which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.) or providing diagnostic information based on such analysis. The device's function is purely for visualization during a surgical procedure.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.
Product codes
HRX
Device Description
The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital NeuroPEN Model number: 2120-515
Description: The Digital NeuroPEN is a sterile, single use, spinal endoscopes with a distal tip camera, light source, and irrigation channel. The Digital NeuroPEN is intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital NeuroPEN terminates in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard HDMI video monitor; the other fitting is an irrigation extension tube with a female Luer lock connector.
The Digital ClarusScope Model number: 2100-500
Description: The Digital ClarusScope is a sterile, single use, spinal endoscope with a distal tip camera, light source, irrigation channel and working channel. The Digital ClarusScope is intended to be used with the non-sterile, reusable video Digital Control Module with standard HDMI output. The proximal end of the Digital ClarusScope terminates in two fittings: the endoscope connector attaches to the Digital Control Module, which interfaces to an HDMI monitor; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital Control Module Model number: 5190-500
Description: The Digital control Module is powered by a medical grade DC power adapter provided with the system. The video image captured from the endoscope is transferred through the Digital Control Module and is output using a standard HDMI video cable which connects to a standard video monitor providing a digital image. The Digital Control Module provides controls for variable illumination level with level indicator along with control for white balance and system.
Mentions image processing
Yes, "Image is digitally processed by control unit with embedded firmware"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in healthcare facilities by qualified healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
The Digital ClarusScope, Digital NeuroPEN, and Digital Control Module have been thoroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the systems:
- Requirements/Specification Reviews
- Design Reviews
- Performance Testing (Verification):
- Endoscope dimensional verification
- Mechanical strength requirements
- Functional Tests
- Endoscope fluid patency
- System image output
- Simulated Use Test
- Interconnection testing between endoscope and control module and accessories
- Compatibility with introducer
- Compatibility of endoscope working channel with accessory devices
- Sterility
- ETO Sterilization Validated per ISO 11135-1
- Shelf-Life per ASTM F1980
- Distribution per ASTM D4169
- Biocompatibility per ISO 10993-1
- Cytotoxicity (MEM Elution)
- Sensitization (Kligman Maximization)
- Irritation (Intracutaneous Injection)
- Systemic Toxicity (Systemic Injection)
- Hemolysis (In direct)
- Materials Mediated Pyrogenicity
- Electrical Safety and Electromagnetic Compatibility
- Particular Safety of Endoscopic Equipment per IEC 60601-2-18
- Basic safety and Essential Performance per IEC 60601-1
- Electromagnetic Immunity and Emissions per IEC 60601-1-2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
April 25, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Clarus Medical, LLC % Alan Vanhouten Quality & Regulatory Consultant Alan VanHouten Biomedical Consulting 916 Ridgecrest Dr Carver, Minnesota 55315
Re: K240535
Trade/Device Name: Digital ClarusScope System; Digital NeuroPEN System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 23, 2024 Received: February 26, 2024
Dear Alan Vanhouten:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Trombetta ---------------------------------------------------------------------------------------------------------------------------------------------------------------
For: Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K240535
Device Name Digital ClarusScope System Digital NeuroPEN System
Indications for Use (Describe)
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
A. General Information:
Submitter:
Clarus Medical, LLC 13355 10th Ave North Minneapolis, MN 55441 763-525-8403
Establishment Number: 2183911
Contact:
Mark F. Brown Director of Operations mbrown@clarus-medical.com
Digital ClarusScope System Digital NeuroPEN System
Date Prepared:
April 23, 2024
arthroscope
arthroscope
HRX
=
B. Trade Name:
Common Name: Product Code: Regulation Number: Regulation Name: Class:
C. Predicate Device:
510(k) Number Description K974579 Clarus Model 2600 Neuro Endoscope
21 CFR 888.1100
D. Reference Devices: 510(k) Number
Description Clarus Digital ClarusScope System and Digital NeuroPEN K223615 System
E. Device Description:
System level description;
The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a
5
K240535
510(K) Summary
standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital NeuroPEN Model number: 2120-515
Description: The Digital NeuroPEN is a sterile, single use, spinal endoscopes with a distal tip camera, light source, and irrigation channel. The Digital NeuroPEN is intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital NeuroPEN terminates in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard HDMI video monitor; the other fitting is an irrigation extension tube with a female Luer lock connector.
The Digital ClarusScope Model number: 2100-500
Description: The Digital ClarusScope is a sterile, single use, spinal endoscope with a distal tip camera, light source, irrigation channel and working channel. The Digital ClarusScope is intended to be used with the non-sterile, reusable video Digital Control Module with standard HDMI output. The proximal end of the Digital ClarusScope terminates in two fittings: the endoscope connector attaches to the Digital Control Module, which interfaces to an HDMI monitor; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital Control Module Model number: 5190-500
Description: The Digital control Module is powered by a medical grade DC power adapter provided with the system. The video image captured from the endoscope is transferred through the Digital Control Module and is output using a standard HDMI video cable which connects to a standard video monitor providing a digital imaqe. The Digital Control Module provides controls for variable illumination level with level indicator along with control for white balance and system.
F. Indications For Use:
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.
6
G. Comparison to Predicate and reference Devices:
The Digital ClarusScope is substantially equivalent to the predicate devices in terms of design, materials, and performance. The predicate and subject device have similar indications and very similar construction.
Differences in Indications for Use:
The Indications for Use is similar to the predicate device. The endoscopes are used for visualization, diagnostic and/or therapeutic procedures of structures within the spine during surgical procedures.
7
K240535 510(K) Summary
Substantial Equivalence table
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device | |||
| Name | Clarus Digital ClarusScope | ||
| System, and Digital | |||
| NeuroPEN System | Clarus Model 2600 Neuro | ||
| Endoscope | Clarus Digital ClarusScope | ||
| System and Digital | |||
| NeuroPEN System | |||
| 510(k) | TBD | K974579 | K223615 |
| Product | |||
| code | HRX | HRX | GWG |
| Indication | |||
| for use | The Digital ClarusScope | ||
| System and Digital | |||
| NeuroPEN System are | |||
| intended for accessing and | |||
| visualizing the spinal nerve | |||
| roots, foramina, | |||
| intervertebral disc, and | |||
| surrounding tissues of the | |||
| spine during discectomy | |||
| procedures, bone and | |||
| osteophyte removal, and | |||
| procedures associated | |||
| with ruptured or herniated | |||
| discs. | The Model 2600 Endoscope | ||
| is intended for accessing | |||
| and visualizing the spinal | |||
| nerve roots, foramina, | |||
| intervertebral disc, and | |||
| surrounding tissues of the | |||
| lumbar spine. The | |||
| endoscope has a working | |||
| channel intended for the | |||
| passage of surgical | |||
| instruments indicated for | |||
| use in this area. Surgical | |||
| instrumentation may be | |||
| used for discectomy | |||
| procedures, bone and | |||
| osteophyte removal, | |||
| procedures associated with | |||
| ruptured or herniated discs, | |||
| such as retrieval of | |||
| extruded disc fragments | |||
| and retrieval of free | |||
| fragments. The endoscope | |||
| also has an irrigation | |||
| channel for irrigation flush | |||
| or aspiration. | The Digital ClarusScope | ||
| System and Digital | |||
| NeuroPEN System are | |||
| intended for use in | |||
| neurosurgery, endoscopic | |||
| neurosurgery, and | |||
| ventriculoscopy for | |||
| visualization of ventricles | |||
| and structures within the | |||
| brain during neurological | |||
| surgical procedures, | |||
| diagnostic and/or | |||
| therapeutic procedures | |||
| such as ventriculostomies, | |||
| biopsies and removal of | |||
| cysts, tumors and other | |||
| obstructions. | |||
| Type of | |||
| scope | Digital ClarusScope; Rigid | ||
| Digital NeuroPEN: | |||
| passively deflective | Rigid | Digital ClarusScope; Rigid | |
| Digital NeuroPEN: | |||
| passively deflective | |||
| Insertion | |||
| shaft | |||
| diameter | 1 to 4.2mm | 4.2 to 5.2 mm | 1 to 4.2mm |
| Insertion | |||
| Shaft | |||
| Length | 13cm Digital ClarusScope | ||
| 15.5cm Digital NeuroPEN | 18.8cm | 13cm Digital ClarusScope | |
| 15.5cm Digital NeuroPEN | |||
| Light | |||
| source | External LED (intensity | ||
| adjustable) | Same | External LED (intensity | |
| adjustable) | |||
| Premarket Notification 510(k) | Clarus Medical, LLC | ||
| Subject Device | Predicate Device | Reference Device | |
| Image acquisition | Distal tip CMOS, color, video, camera | Lens and imaging fiberoptics at distal tip | Distal tip CMOS, color, video, camera |
| Image processing | Image is digitally processed by control unit with embedded firmware | None | Image is digitally processed by control unit with embedded firmware |
| Image display | External display monitor connection | External display with camera system or viewed through eyepiece | External display monitor connection |
| Sterile | EO | Provided non sterile; EO compatible | EO |
| Use | Single Use | Reusable | Single Use |
| Image control Box | Electronics (Circuit boards, CPU with firmware control), Keypad buttons for illumination adjustment by user | None | Electronics (Circuit boards, CPU with firmware control), Keypad buttons for illumination adjustment by user |
8
9
510(K) Summary
H. Non-Clinical Performance Data:
The Digital ClarusScope, Digital NeuroPEN, and Digital Control Module have been thoroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the systems:
- Requirements/Specification Reviews ●
- Design Reviews
- Performance Testing (Verification): ●
- Endoscope dimensional verification
- Mechanical strength requirements o
- Functional Tests
- o Endoscope fluid patency
- System image output o
- Simulated Use Test ●
- Interconnection testing between endoscope and control module and accessories o
- Compatibility with introducer o
- Compatibility of endoscope working channel with accessory devices O
Sterility
- . ETO Sterilization Validated per ISO 11135-1
- Shelf-Life per ASTM F1980 ●
- Distribution per ASTM D4169 ●
Biocompatibility per ISO 10993-1
- . Cytotoxicity (MEM Elution)
- -Sensitization (Kligman Maximization)
- -Irritation (Intracutaneous Injection) ●
- -Systemic Toxicity (Systemic Injection) ●
- -Hemolysis (In direct)
- -Materials Mediated Pyrogenicity ●
Electrical Safety and Electromagnetic Compatibility
- Particular Safety of Endoscopic Equipment per IEC 60601-2-18 .
- Basic safety and Essential Performance per IEC 60601-1
- . Electromagnetic Immunity and Emissions per IEC 60601-1-2
10
Comparison to Predicate and reference devices: .
The Digital ClarusScope System and Digital NeuroPEN System are substantially equivalent to the predicate based on the following technological elements:
- Design: The construction of the subject device and predicate are similar by providing a visual image of the surgical site. The predicate device transmits an analog image through the endoscope using fiber optics. The subject devices incorporate a CMOS digital imaging sensor at the distal tip of the endoscope. The digital signal is transmitted through the endoscope to the Digital Control Module. The predicate and subject devices all makes use of a control box to allow for light output and white balance adjustment.
- . Materials: The materials of the subject devices, predicate, and references are very similar medical grade stainless steel and or plastics.
- Environment of Use: The subject device, predicate, and reference device are ● used in healthcare facilities by qualified healthcare professionals.
The following technological differences exist between the subject and predicate devices:
The construction of the subject device and the predicate are the same with the addition of a distal tip camera in the subject device. The subject device also makes use of a control box to allow for light output and white balance adjustment.
Substantial Equivalence Conclusion:
Clarus Medical has demonstrated through performance testing, design and non-clinical testing that the proposed subject device and the predicate device have been found to be substantially equivalent.